FDA: Major Drug Manufacturers Asked to Include Warnings on Arthritis Meds
Major Medicine Manufacturers– Pfizer (PFE.N), Eli Lilly & Co (LLY.N), and AbbVie (ABBV.N) were asked by the Food and Drug Administration to include new warnings on their medical products, most particularly their arthritis drugs.
The medicines in question are called JAK inhibitors, after the inflammation-causing enzymes Janus Kinases which then cause the diseases such as rheumatoid arthritis and ulcerative colitis. JAK inhibitors are meant to fight off these enzymes.
However, concerns rose after results from a February trial showed an increased risk of serious heart-related problems and cancer with the drug manufactured by Pfizer, Xeljanz. The trial also found that Xeljanz had mechanisms associated with blood clots and eventual death.
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AbbVie’s arthritis drug, Rinvoq, and Lilly’s drug, Olumiant reportedly had similar qualities, which prompts possible effects as seen in Pfizer’s trial.
Pfizer says adding additional warning labels would be helpful on the risks and benefits of the medicine they are manufacturing.
According to Lilly, “Based on available data across approved and investigational indications, we remain confident in the positive benefit-risk profile of Olumiant.”
Meanwhile, AbbVie has not given a comment on the issue. Shares of the three companies notably went lower after the FDA warning, with AbbVie closing down 7% of its shares.
Bloomberg reports that around $20 billion were lost in market value by AbbVie, which is the biggest loss after March 2020.